Clinical Trial: Urotherapy vs. Urotherapy With Constipation Treatment for Nocturnal Enuresis

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: A Controlled Randomized, Physician Blinded Study to Assess Isolated Uro-therapy vs. Urotherapy With Constipation Treatment for Patients With Moderate-severe Monosymptomatic Noctu

Brief Summary: Constipation treatment has been found to ameliorate symptoms in some patients with nocturnal enuresis (bed wetting at night). This study aims to explore if treatment of patients without overt constipation (As defined by the ROME III criteria) will also respond to stool softening and GI behavioral therapy with reduction of their urinary tract symptoms when added to standard urotherapy.

Detailed Summary:
Sponsor: Rabin Medical Center

Current Primary Outcome: Number of participants with complete (no nocturnal enuresis) or partial (A decease in nocturnal enuresis episodes of 50% or more) response at week 14 [ Time Frame: 14 weeks ]

Proportion of patients with uro-therapy + constipation treatment with complete (No nocturnal enuresis) or partial (A decease in nocturnal enuresis episodes of 50% or more) response in comparison to the isolated urotherapy group.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Number of participants with complete (no nocturnal enuresis) or Partial (A decease in nocturnal enuresis episodes of 50% or more) response of enuresis to treatment in patient subgroups with fecal loading compared to those without fecal loading. [ Time Frame: 14 weeks ]
    Complete (no nocturnal enuresis) or Partial (A decease in nocturnal enuresis episodes of 50% or more) response to therapy in those with radiological evidence of fecal loading on enrollment abdominal x-ray (as defined by rectal/pelvic outlet ratio, Leech score, and Barr score) compared to those who did not in the intervention group and the urotherapy group.
  • Number of participants with sustained complete (no nocturnal enuresis) or partial (A decease in nocturnal enuresis episodes of 50% or more) response 12 weeks after the end of the intervention. [ Time Frame: 26 weeks ]
    Sustained complete (no nocturnal enuresis) or Partial (A decease in nocturnal enuresis episodes of 50% or more) response at 26 weeks.
  • Number of participants with adverse effects [ Time Frame: 14 weeks ]
    Adverse effects of interventions as reported by patients/care givers during visits.


Original Secondary Outcome: Same as current

Information By: Rabin Medical Center

Dates:
Date Received: January 1, 2015
Date Started: January 2016
Date Completion:
Last Updated: October 26, 2015
Last Verified: October 2015